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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01091-1
Product Name/Description	0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml 0.9% Sodium Chloride for Irrigation 2000ml Product Code: AHB7616 Batch Numbers: S77N6 & S77R8 (Expiry Date: July 2016) and S78F1 (Expiry Date: Aug 2016) Water for Irrigation 2000ml Product Code: AHB7606 Batch Numbers: S77N5 (Expiry Date: July 2016) and S78A6 (Expiry Date: Aug 2016) ARTG Number: 155928
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	10/10/2014
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	Investigation of a small number of customer complaints has confirmed a reported problem of solution leaking into the overpouch. It has been identified that the issue was caused by a component used in the manufacture of the lots above, and is confined to these batches. There are no other affected products. This issue potentially impacts the sterility of the irrigation fluid.
Recall Action	Recall
Recall Action Instructions	Customers are advised to locate and remove all of the affected products and lot numbers from their facility. The affected product should be returned for credit by contacting Baxter Healthcare Customer Service. Also, customers are advised to bring this matter to the attention of relevant prescribers within their hospital so that any patient who is undergoing infusion, or has very recently received an infusion of this product, can be monitored. This action has been closed-out on 22/08/2016.
Contact Information	1300 789 646 - Baxter Healthcare Customer Service